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Publication numberUS6585695 B1
Publication typeGrant
Application numberUS 09/428,818
Publication dateJul 1, 2003
Filing dateOct 28, 1999
Priority dateOct 29, 1998
Fee statusPaid
Also published asCA2345439A1, CA2345439C, CA2346525A1, CA2346525C, CA2533850A1, CA2533850C, CA2669175A1, CA2669175C, CA2832936A1, DE69923858D1, DE69923858T2, DE69928827D1, DE69928827T2, DE69943207D1, EP1124600A1, EP1124600B1, EP1124608A1, EP1124608B1, EP1642615A2, EP1642615A3, EP1642615B1, EP1716884A1, EP1716884B1, EP2204203A2, EP2223713A2, US6362591, US6555986, US7628782, US7658734, US7981105, US7988683, US7998131, US8257345, US8303572, US8500716, US20020043951, US20030125672, US20040003493, US20050021000, US20090137979, US20100049135, US20100082010, US20100125247, US20110238031, US20130018357, US20130310807, WO2000025844A1, WO2000025852A1
Publication number09428818, 428818, US 6585695 B1, US 6585695B1, US-B1-6585695, US6585695 B1, US6585695B1
InventorsRandy W. Adair, Sheldon Moberg, Chalirmkiert Srisathapat
Original AssigneeMinimed Inc.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Reservoir connector
US 6585695 B1
Abstract
A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. A base is provided which is adapted to receive a reservoir. The base has a base engagement member, such as a detent, projecting therefrom. A cap is provided which is adapted to receive the base. The cap includes a first cap engagement member, such as a detent opening, which is adapted to removably engage the base detent. The cap further includes a second cap detent opening which is adapted to removably engage the base detent. A piercing member, such as a needle, is disposed in the interior of the cap in such a manner that the needle is separated from the reservoir septum when the base detent is in the first cap detent opening, and the needle pierces the reservoir septum when the base detent is in the second cap detent opening. When the reservoir, the base and the cap are connected to form an integrated unit, this unit is then capable of being inserted and secured in the infusion pump housing.
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Claims(44)
What is claimed is:
1. An apparatus for connecting a reservoir having a septum and a base to a conduit, the apparatus comprising:
a cap having a piercing member that is coupled with the conduit and a vent port in the cap, the vent port covered with hydrophobic material, wherein the vent port permits the passage of air and inhibits the passage of fluids;
a releasable coupler adapted to releasably couple the base with the cap in one of a first and a second position; and
wherein the piercing member is disposed in the cap in a position other than the interior of the reservoir when the base is coupled in the first position, and the piercing member is disposed in the cap to pierce the reservoir septum when the base is coupled in the second position.
2. An apparatus for connecting a reservoir having a septum and a base to a conduit and to a housing having a housing engagement member, said apparatus comprising:
a cap having a piercing member that is coupled with the conduit and including means for venting the housing to the atmosphere without permitting liquids to pass through the venting means;
a releasable coupler adapted to releasably couple the base with the cap in one of a first and a second position;
wherein the piercing member disposed in the cap in a position other than the interior of the reservoir when the base is coupled in the first position, and the piercing member disposed in the cap to pierce the reservoir septum when the base is coupled in the second position; and
a cap engagement member disposed on the cap, the cap engagement member adapted to engage the housing engagement member.
3. The apparatus of claim 2 wherein the cap further comprises a second cap engagement member adapted to engage the housing.
4. The apparatus of claim 2 further comprising a vent port in the cap, the vent port covered with a hydrophobic material.
5. The apparatus of claim 2 wherein the cap further comprises a shoulder adapted to sealingly engage the housing.
6. A method of connecting a reservoir having a septum and a base to a conduit, the method comprising:
inserting the base into a cap having a piercing member and a coupler, the piercing member coupled to the conduit, and the coupler adapted to releasably couple the base with the cap in one of a first and a second position;
releasably coupling the base to the cap in the first position whereby the piercing member is disposed in the cap in a position other than the interior of the reservoir;
releasably coupling the base to the cap in the second position whereby the piercing member is disposed in the cap to pierce the reservoir septum; and
venting the housing through a vent port in the cap, said vent port containing hydrophobic material.
7. The method of claim 6 wherein the cap further comprises a second releasable coupler, said method further comprising:
coupling the reservoir, the base and the cap to a housing whereby the second releasable coupler releasably engages with the housing.
8. The method of claim 6 wherein the cap further comprises a cap engagement member adapted to engage the exterior of a housing.
9. A method of connecting a reservoir to a housing and to a conduit, said reservoir having a septum and a base with a detent tab, and said housing having a first thread member, the method comprising:
inserting the base to a first detent position in a cap having a piercing member coupled to the conduit and a second thread member, whereby the piercing member is disposed in the cap to be at a position other than the interior of the reservoir;
inserting the base to a second detent position in the cap whereby the piercing member is disposed in the cap to pierce the reservoir septum;
connecting the reservoir, the base and the cap to the housing whereby the second thread member engages with the first thread member; and
venting the housing through a vent that permits the passage of air and simultaneously inhibits the passage of fluids.
10. An apparatus for connecting a reservoir having a septum and a base to a conduit, said apparatus comprising:
a cap adapted to receive the base;
means in the cap for piercing the reservoir septum;
means for removably coupling the base with the cap in one of a first and a second position whereby the piercing means is disposed in the cap and does not pierce the reservoir septum when the base is coupled in the first position and whereby the piercing means is disposed in the cap and pierces the reservoir septum when the base is coupled in the second position;
means for coupling the piercing means with the conduit; and
means for permitting air to flow through an opening in the cap without permitting liquids to pass through the opening.
11. An apparatus for connecting a reservoir having a septum and a base to a housing and to a conduit, said apparatus comprising:
a cap adapted to receive the base;
means in the cap for piercing the reservoir septum;
means for removably coupling the base with the cap in one of a first and a second position whereby the piercing means is disposed in the cap and does not pierce the reservoir septum when the base is coupled in the first position and whereby the piercing means is disposed in the cap an pierces the reservoir septum when the base is coupled in the second position;
means for coupling the piercing means with the conduit;
means for removably engaging the cap with the housing; and
a vent that permits the passage of air and simultaneously inhibits the passage of fluids.
12. An apparatus for connecting a reservoir having a septum to a conduit, said conduit coupled to a piercing member disposed in a cap, the apparatus comprising:
a base adapted to receive the reservoir and to be received by the cap;
a releasable coupler adapted to releasably couple the base and the reservoir with the cap in one of a first and a second position;
said releasable coupler adapted to position the reservoir septum whereby the piercing member is disposed in the cap in a position other than the interior of the reservoir when the base and reservoir are coupled in the first position, and to position the reservoir septum to be pierced by the piercing member when the base and the reservoir are coupled in the second position; and
a vent that permits the passage of air and simultaneously inhibits the passage of fluids.
13. An apparatus for connecting a reservoir having a septum and a base to a conduit, the apparatus comprising:
a cap adapted to receive the base and having a piercing member;
a releasable coupler adapted to releasably couple the base with the cap; and
a vent port in the cap, the vent port covered with hydrophobic material;
wherein the piercing member is coupled to the conduit and disposed in the cap to pierce the reservoir septum when the base is inserted into the cap.
14. An apparatus for connecting a reservoir having a septum and a base to a conduit and to a housing having a housing engagement member, said apparatus comprising:
a cap adapted to receive the base and having a piercing member and means for venting the housing to the atmosphere without permitting liquids to pass through the venting means;
a releasable coupler adapted to releasably couple the base with the cap;
wherein the piercing member is coupled to the conduit and disposed to pierce the reservoir septum when the base is inserted in the cap; and
a cap engagement member disposed on the cap, the cap engagement member adapted to engage the housing engagement member.
15. The apparatus of claim 14 wherein the cap further comprises a second cap engagement member adapted to engage the housing.
16. The apparatus of claim 14 further comprising a vent port in the cap, the vent port covered with a hydrophobic material.
17. The apparatus of claim 14 wherein the cap further comprises a shoulder adapted to sealingly engage the housing.
18. An apparatus for connecting a reservoir having a septum to a conduit and to a housing having a first thread member, the apparatus comprising:
a base adapted to receive the reservoir;
a detent tab projecting from the base;
a cap adapted to receive the base, said cap having a piercing member and a longitudinal entry slot adapted to receive the detent tab and a vent that permits the passage of air and simultaneously and inhibits the passage of fluids;
an annular stop shoulder disposed in the cap at the distal end of the entry slot to prevent further longitudinal movement of the detent tab;
said cap having a detent opening formed adjacent to the annular stop shoulder and adapted to removably engage the detent tab;
a cam surface disposed between the distal end of the entry slot and the detent opening to permit the detent tab to travel from the distal end of the entry slot and to engage the detent opening;
wherein the piercing member is coupled to the conduit and disposed in the cap to pierce the reservoir septum when the base and reservoir are inserted in the cap; and
a second thread member disposed on the cap, the second thread member adapted to engage the first thread member.
19. A method of connecting a reservoir having a septum and a base to a conduit, the method comprising:
inserting the base and reservoir into a cap having a piercing member and a coupler and a second releasable coupler, the piercing member coupled to the conduit, and the coupler adapted to releasably couple the base with the cap;
piercing the reservoir septum with the piercing member disposed in the cap;
releasably coupling the base to the cap;
coupling the reservoir, the base and the cap to a housing whereby the second releasable coupler releasably engages with the housing; and
venting the housing through a vent port in the cap, said vent port containing hydrophobic material.
20. The method of claim 19 wherein the cap further comprises a cap engagement member adapted to engage the exterior of the housing.
21. A method of connecting a reservoir to a housing and to a conduit, said reservoir having a septum and a base with a detent tab, and said housing having a first thread member, the method comprising:
inserting the base and reservoir into a cap having
(i) a piercing member coupled to the conduit;
(ii) a longitudial entry slot adapted to receive the detent tab;
(iii) an annular stop shoulder disposed at the distal end of the entry slot to prevent further longitudinal movement of the detent tab;
(iv) a detent opening formed adjacent to the annular stop shoulder and adapted to removably engage the detent tab; and
(v) a cam surface disposed between the distal end of the entry slot and the detent opening to permit the detent tab to travel from the distal end of the entry slot and to engage the detent opening;
sliding the base and reservoir in the cap until the detent tab abuts the annular stop shoulder;
piercing the septum with the piercing member;
twisting the base and reservoir inside the cap until the detent tab releasably engages with the detent opening by traveling over the cam surface; and
connecting the reservoir, the base and the cap to the housing whereby the second thread member engages with the first thread member.
22. An apparatus for connecting a reservoir having a septum and a base to a conduit, said apparatus comprising:
a cap having a piercing means and adapted to receive the base;
wherein the piercing means is disposed in the cap for piercing the reservoir septum;
means for removably coupling the base and the reservoir with the cap whereby the piercing means is disposed in the cap and pierces the reservoir septum when the base and reservoir are coupled to the cap;
means for coupling the piercing means with the conduit; and
means for permitting air to flow through an opening in the cap without permitting liquids to pass through the opening.
23. An apparatus for connecting a reservoir having a septum and a base to a housing and to a conduit, said apparatus comprising:
a cap having a piercing means adapted to receive the base and a vent that permits the passage of air and simultaneously inhibits the passage of fluids;
means in the cap for piercing the reservoir septum;
means for removably coupling the base and the reservoir with the cap
wherein the piercing means pierces the reservoir septum when the base and reservoir are coupled to the cap;
means for coupling the piercing means with the conduit; and
means for removably engaging the cap with the housing.
24. An apparatus for connecting a reservoir having a septum to a conduit, said conduit coupled to a piercing member disposed in a cap, the apparatus comprising:
a base adapted to receive the reservoir and to be received by the cap;
a releasable coupler adapted to releasably couple the base with the cap; and
said releasable coupler adapted to position the reservoir septum to be pierced by the piercing member when the base and reservoir is inserted into the cap;
wherein the cap includes a vent that permits the passage of air and simultaneously inhibits the passage of fluids.
25. An apparatus for connecting a reservoir having a septum to a conduit, said conduit coupled to a piercing member disposed in a cap, said cap having a longitudinal entry slot, an annular stop shoulder disposed at the distal end of the entry slot, a detent opening formed adjacent to the annular stop shoulder, a cam surface disposed between the distal end of the entry slot and the detent opening, the apparatus comprising:
a base adapted to receive the reservoir and to be received by the cap;
a detent tab projecting from the base, said detent tab adapted to slidably engage the entry slot until said detent tab abuts the annular stop shoulder;
said detent tab adapted to removably engage the detent opening by traveling over the cam surface; and
said detent tab disposed on the base to position the reservoir septum to be pierced by the piercing member when the detent tab abuts the annular stop shoulder;
wherein the cap includes a vent that permits the passage of air and simultaneously inhibits the passage of fluids.
26. An apparatus for connecting a syringe to a medication pump housing having a first thread member, the apparatus comprising:
an adapter having a substantially cylindrical shape;
said adapter adapted to axially receive the syringe through the center of the adapter;
a sealing member disposed in the adapter to sealingly engage the syringe;
a shoulder disposed on the adapter to sealingly engage the pump housing; and
a second thread member disposed on the adapter, the second thread member adapted to engage the first thread member; and
means disposed on the adapter for venting the pump housing to the atmosphere without permitting liquid to pass through the venting means.
27. The apparatus of claim 26 further comprising an engagement member disposed on the adapter, said engagement member adapted to engage the exterior of the pump housing.
28. An apparatus for connecting a reservoir having a septum to a conduit, the apparatus comprising:
a cap having a piercing member that is coupled with the conduit and a vent that permits the passage of air and simultaneously inhibits the passage of fluids;
a coupler adapted to releasably couple the reservoir with the cap;
wherein the piercing member is disposed in the cap to pierce the reservoir septum when the reservoir is releasably coupled and operatively engaged with the cap.
29. The apparatus of claim 28, wherein the piercing member pierces the septum and is disposed in a position in the interior of the reservoir when the reservoir is releasably coupled with the cap.
30. The apparatus of claim 28, wherein the piercing member is disposed in a position other than the interior of the reservoir when the reservoir is releasably coupled in a first position and the piercing member pierces the reservoir septum and is disposed in a position in the interior of the reservoir when the reservoir is releasably coupled and operatively engaged with the cap in a second position.
31. The apparatus of claim 28, wherein the vent includes a hydrophobic material.
32. The apparatus of claim 28, the cap comprises a cap engagement member adapted to engage a housing engagement member of a housing when the reservoir is releasably coupled and operatively engaged with the cap and the so coupled and engaged reservoir and cap are engaged with the housing.
33. The apparatus of claim 32, wherein the cap further comprises a second cap engagement member adapted to secure the cap to the housing when the reservoir is releasably coupled and operatively engaged with the cap and the so coupled and engaged reservoir and cap are engaged with the housing.
34. The apparatus of claim 28, wherein the cap is coupleable to the reservoir via a base adapted to provide an interface between the reservoir and the cap.
35. The apparatus of claim 28, wherein the cap further comprises a cap engagement member adapted to engage a housing engagement member of a housing and a shoulder to form a seal with the housing when the cap is engaged with the housing.
36. The apparatus of claim 28, wherein the piercing member is a needle which creates a hole in the reservoir septum.
37. The apparatus of claim 31, wherein air passes through the hydrophobic material.
38. The apparatus of claim 31, wherein the hydrophobic material comprises a sphere pressed into a cavity in the cap.
39. The apparatus of claim 31, wherein the hydrophobic material comprises a cylinder pressed into a cavity in the cap.
40. The apparatus of claim 31, wherein the hydrophobic material comprises a label affixed to the cap.
41. The apparatus of claim 31, wherein the hydrophobic material is disposed on an interior surface of the cap.
42. The apparatus of claim 31, wherein the hydrophobic material is disposed on an exterior surface of the cap.
43. An apparatus for connecting a reservoir to a conduit; the apparatus comprising:
a cap for coupling a reservoir to a conduit;
a piercing member disposed in the cap; and
a vent in the cap that permits the passage of air and simultaneously inhibits the passage of fluids.
44. The apparatus of claim 43, wherein the piercing member is disposed in the cap to pierce a reservoir septum that is coupled to the reservoir when the cap is coupled and operatively engaged with the reservoir.
Description

This claims priority from provisional patent application No. 60/106,237 which was filed on Oct. 29, 1998 and which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to improvements in syringe and reservoir interfaces for use in infusion pumps such as those used for controlled delivery of medication to a patient. More specifically, this invention relates to an improved connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump.

2. Description of the Related Art

Infusion pump devices and systems are relatively well-known in the medical arts, for use in delivering or dispensing a prescribed medication such as insulin to a patient. In one form, such devices comprise a relatively compact pump housing adapted to receive a syringe or reservoir carrying a prescribed medication for administration to the patient through infusion tubing and an associated catheter.

The infusion pump includes a small drive motor connected via a lead screw assembly for motor-driven advancement of a reservoir piston to administer the medication to the user. Programmable controls are normally provided for operating the drive motor continuously or at periodic intervals to obtain a closely controlled and accurate delivery of the medication over an extended period of time. Such infusion pumps are utilized to administer insulin and other medications, with exemplary pump constructions being shown and described in U.S. Pat. Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653 and 5,097,122, which are incorporated by reference herein.

Infusion pumps of the general type described above have provided significant advantages and benefits with respect to accurate delivery of medication or other fluids over an extended period of time. The infusion pump can be designed to be relatively compact as well as water resistant, and may thus be adapted to be carried by the user, for example, by means of a belt clip. As a result, important medication can be delivered to the user with precision and in an automated manner, without significant restriction on the user's mobility or life-style, including the ability to participate in water sports.

Infusion sets refer to the tubing and connection apparatus which provide a path for the medication to flow from the reservoir or syringe located in the pump to the user. The connectors for attaching the infusion set tubing to the reservoirs can take various forms. A luer connection is a commonly used connection method. Nevertheless, it remains desirable to develop improved designs of connection methods to facilitate infusion procedures and to provide suitable interface connections which are water resistant so as to permit a user to participate in water sports.

SUMMARY OF THE PREFERRED EMBODIMENTS

An apparatus for connecting a reservoir having a septum and a base to a conduit, such as infusion set tubing, is provided. In certain aspects of the present invention, the apparatus comprises a cap and a releasable coupler which is adapted to releasably couple the base to the cap in one of two positions. A piercing member, such as a needle, is coupled to the conduit. The needle is disposed in the cap in a position other than the interior of the reservoir when the base is in the first position. The needle is further disposed to pierce the reservoir septum when the base is in the second position.

In another embodiment, the apparatus is used for connecting a reservoir having a septum and a base to a housing as well as to a conduit. The housing has a housing engagement member, such as a thread. The apparatus comprises a cap and a releasable coupler which is adapted to releasably couple the base to the cap in one of two positions. A piercing member, such as a needle, is releasably coupled to the conduit. The needle is disposed in the cap in a position other than the interior of the reservoir when the base is in the first position. The needle is further disposed to pierce the reservoir septum when the base is in the second position. The cap further includes an engagement member, such as a thread, which is adapted to engage with the housing engagement member.

In another embodiment, the cap further includes a vent port which is covered with hydrophobic material. This permits air to pass through the cap while preventing water from doing so.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded, perspective view of a medication reservoir connection interface apparatus.

FIG. 2 is a perspective view of a cap used as a medication reservoir connection interface apparatus.

FIG. 3 is an exploded, perspective view of an alternative embodiment of a medication reservoir connection interface apparatus.

FIG. 4 is a side, cut-away view of a cap used as a medication reservoir connection interface apparatus.

FIG. 5 is a side, plan cut-away view of a medication reservoir connection interface apparatus with a needle inserted into a reservoir.

FIG. 6 is a side, plan cut-away view of a medication reservoir connection interface apparatus which is inserted into a pump housing.

FIG. 7 is a perspective view of an alternative embodiment of a medication reservoir connection interface apparatus.

FIG. 8 is a perspective top view of an alternative embodiment of a medication reservoir connection interface apparatus which is secured into a pump housing.

FIG. 9 is a perspective view of an alternative embodiment of a medication reservoir connection interface apparatus.

FIG. 10 is an exploded, perspective view of a cap used as a medication reservoir connection interface apparatus.

FIG. 11 is a perspective view of a medication reservoir connection interface adapter.

FIG. 12 is a cross-sectional view of a medication reservoir connection interface adapter.

FIG. 13 is a perspective view of an alternative embodiment of a cap used as a medication reservoir connection interface apparatus.

FIGS. 14a-14 c are cross-sectional views of various embodiments of venting ports for use with a reservoir connection interface apparatus or adapter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the following description, reference is made to the accompanying drawings which form a part hereof and which illustrate several embodiments of the present invention. It is understood that other embodiments may be utilized and structural and operational changes may be made without departing from the scope of the present invention.

As shown in the drawings for purposes of illustration, the invention is embodied in an interface for connecting a syringe or a medication reservoir to a conduit, such as infusion set tubing or an external needle, as well as to an infusion pump. In a one embodiment, a base is provided which is adapted to receive a reservoir. A cap is provided which is adapted to be releasably coupled to the base in one of two positions. The releasable coupler comprises a pair of detents projecting from the base and two pairs of detent openings in the cap which are adapted to removably engage the base detents.

A piercing member, such as a needle, is disposed in the interior of the cap in such a manner that the needle is separated from the reservoir septum when the base detents are in the first pair of cap detent openings, and the needle pierces the reservoir septum when the base detents are in the second pair of cap detent openings. When the reservoir, the base and the cap are connected, an integrated unit is formed which is then capable of being inserted in the infusion pump housing. Engagement members, such as threads, for the cap and the pump housing are used to secure the integrated unit in the housing.

FIGS. 1 and 2 show an infusion set connector interface for attachment to a medication reservoir. The connector interface is comprised of a base 2 and a cap 4. The cap 4 includes a needle 9 located internal to the cap housing. FIG. 1 is an exploded view, and therefore, the base 2 would normally be fixedly attached to a reservoir 1 by securing it around the swage 3. However, alternative embodiments of the present invention include a removable base so that the connector interface could be used with standard reservoirs, cartridges or syringes which were not initially manufactured with the base attached.

The cap 4 portion of the connector interface is removably attached to the base 2 with a releasable coupler. In one embodiment, the releasable coupler is comprised of detents formed on the base 2 and detent openings disposed in the cap 4. Two detents 8 are disposed on the sides of the base 2 and are spaced 180° radially apart. Only one detent 8 is shown in FIG. 1. The detents 8 are sized to fit in the two lower detent openings 6, or alternatively, in the two upper detent openings 7 which are formed in the cap 4. As with the pair of detents 8, each of the lower detent openings 6 and each of the upper detent openings 7, respectively, are radially spaced apart by 180°.

In operation, the base 2 and the reservoir 1 form an integrated unit which in turn is to be connected to the cap 4. In connecting this integrated base/reservoir unit to the cap 4, the base 2 is inserted into the lower end of the cap 4 until the detents 8 snap into the lower detent openings 6. This is accomplished by moving the detents 8 over internal cam surfaces 10 toward the lower detent openings 6. The cam surfaces act as ramps which compress the detents 8 sufficiently to permit them to snap into the lower detent openings 6. Internal threads 10 a guide the detents 8 into position.

When the base/reservoir unit is in this first, lower position, the needle 9 is positioned apart from the septum (not shown) of the reservoir 1. Thus the needle does not pierce the septum while the base/reservoir unit is in this first position. When the base/reservoir unit is connected to the cap in this fashion, an integrated cap/base/reservoir unit is thereby formed. Such an integrated cap/base/reservoir unit can be sold or stored for long periods of time in this fashion. Alternatively the end user could assemble this unit shortly prior to placing it in the pump for use.

When the user desires to insert the cap/base/reservoir unit in the pump housing and commence dispensing the medication through a conduit, such as insertion set tubing 5, the base 2 is moved to the second position within the cap 4. This is accomplished by twisting the base/reservoir unit while pushing it further into the cap 4. The detents 8 disengage from the lower detent openings 6 and engage into the upper detent openings 7. Additional internal threads 10 a of the cap 4 serve to guide the detents 8 over additional cam surfaces 10 from their first position in the lower detent openings 6 to the second position in the upper detent openings 7.

In one embodiment, the threads and the spacing between the lower detents 6 and the upper detents 7 is such that a one quarter (¼) turn of the base will cause the base/reservoir unit to travel from the first to the second position. The needle 9 is disposed so that when the base/reservoir unit is in the second position, the needle pierces the septum of the reservoir 1. Thus the movement of the base/reservoir unit from the first to the second position within the cap serves to cause the needle to pierce the reservoir's septum, thus permitting the fluid in the reservoir to flow into the needle 9 and the insertion set tubing 5.

After this connection is made, the reservoir, base and cap form a unit which can be releasably secured in the housing of a medication infusion pump. (not shown) Detents 4 a extend radially from the exterior of the cap and are adapted to engage into detent openings (not shown) in the pump housing. In an alternative embodiment, the cap 4 can include external threads (not shown) which are used to engage the threads of the pump housing in order to secure the reservoir/base/cap unit into the housing.

FIGS. 3 and 4 show an alternative embodiment of the infusion set connector interface. The connector interface is comprised of a base 11 and a cap 12. The cap 12 includes a needle 18 located internal to the cap housing (FIG. 4). The base 11 would normally be fixedly attached to the reservoir 1 by securing it around the swage 3. However, alternative embodiments of the present invention include a removable base so that the connector interface could be used with standard reservoirs, cartridges or syringes which were not initially manufactured with the base attached.

The cap 12 portion of the connector interface is removably attached to the base 11 with a releasable coupler. In this embodiment, the releasable coupler is comprised of detents formed on the base 11 and detent openings disposed in the cap 12. Two detents 13 are disposed on the sides of the base 11 and are spaced 180° radially apart. Only one detent 13 is shown in FIG. 3. The detents 13 are sized to fit in two detent openings 14 which are formed in the cap 12. As with the pair of detents 13, each of the detent openings 14 are radially spaced apart by 180°.

In operation, the base 11 and the reservoir 1 form an integrated unit which in turn is to be connected to the cap 12. In connecting this integrated base/reservoir unit to the cap 12, the base 11 is inserted into the lower end of the cap 12. The detents 13 slide into matingly shaped and longitudinally open entry slots 15 formed within the interior walls of the cap 12. When the base 11 is fully inserted in the cap 12, the leading edges of the detents 13 abut an annular stop shoulder 16 formed within the cap 12. After the detents 13 are in this position, the base 11 is rotated within the cap 12 toward a locked position. Referring to FIG. 4, this rotation displaces the detents 13 in a rotational direction for engagement with cam surfaces 17 formed within the cap 12. The rotational force on the detents 13 over the cam surfaces 17 provides a compression force on the detents 13. Continued rotation of the base 11 displaces the detents 13 past the cam surfaces 17 and into alignment with the detent openings 14. The detents 13 enter the detent openings 14 with a snap-action. Thus, the detents 13 are effectively locked within the detent openings 14 to prevent longitudinal separation of the base 11 from the cap 12.

In the preferred embodiment, the internal needle 18 of the cap 12 is disposed so that when the base/reservoir unit is fully inserted in the cap 12, the needle pierces the septum (not shown) of the reservoir 1. Thus the insertion force of the base/reservoir unit to the point where the detents 13 abut the annular stop shoulder 16 causes the needle 18 to pierce the septum, thus permitting the fluid in the reservoir to flow into the needle 18 and the insertion set tubing (not shown).

After this connection is made, the reservoir, base and cap form a unit which can be releasably secured in the housing of a medication infusion pump. (not shown) The cap 12 includes external threads 19 which are used to engage the threads of the pump housing in order to secure the reservoir/base/cap unit into the housing. In the preferred embodiment, the threads 19 have an eight threads per inch (“TPI”), 2 start profile. Moreover, they have a square shaped cross section which maximizes their holding strength. Other thread profiles and cross-sections may be used however.

When disconnection of the base 11 from the cap 12 is desired, the base 11 must be reverse-rotated within the cap 12, to move the detents 13 past the cam surfaces 17 into re-alignment with the entry slots 15. Such reverse-rotation of the coupler can be performed relatively easily, but essentially requires an affirmative intent by the user to disconnect the coupling. When the detents 13 are re-aligned with the entry slots 15, the cap 12 and base 11 can be separated easily with minimal longitudinal force.

FIG. 5 shows a cross sectional view of the reservoir/base/cap integrated unit in accordance with the embodiment of FIGS. 3 and 4. The reservoir 1 includes a crimp seal swage 3 which encloses the outer periphery of the rubber septum 20 in order to secure the septum 20 to the reservoir 1 and form a water tight seal. With the base 11 in the locked position as shown, the detents 13 of the base 11 are locked into the detent openings 14 to securely attach the base/reservoir unit into the cap 12. The needle 18 pierces the rubber septum 20, thus permitting the flow of liquid through the needle 18 and into the infusion set tubing cavity 22. Infusion set tubing (not shown) is secured into the cavity 22 to allow the liquid to continue its flow to the user.

In the preferred embodiment, the conduit from the cap 12 is infusion set tubing. However in an alternative embodiment, the conduit comprises a second needle (not shown). This is secured into the cavity 22 with the point of the second needle extending outward. With this arrangement, the connector serves as an apparatus for permitting the refilling of the reservoir 1. The second, external needle would pierce the septum of a supply vial of fluid. The fluid could then be drawn into the cap in a reverse flow and into the reservoir 1 via the internal needle 18.

In the embodiment shown in FIG. 5, infusion set tubing is secured to the cavity 22 to allow liquid to flow to the user. The cavity 22 is disposed in the raised portion of the cap 12. In an alternative embodiment, however, the raised portion of the cap 12 can be in the shape of a standard luer fitting 47 shown in FIG. 13.

Referring to FIG. 5, in one embodiment the base 11 is formed around and fixedly attached to the crimp seal swage 3 portion of the reservoir 1. In an alternative embodiment, however, the base 11 is not fixedly attached to the reservoir. Rather, the base 11 is a separate unit which is adapted to be releasably secured to the reservoir via a friction fit. This arrangement permits the connector apparatus to be used with standard reservoirs.

Still referring to FIG. 5, the cap 12 includes threads 19 for securing the assembly into the pump housing (not shown). A shoulder 23 is formed as part of the cap 12 and is adapted to seat against the pump housing to form a water tight seal. This prevents any water which is exterior to the housing from entering, thus permitting the user to engage in water sports.

The construction of these pumps to be water resistant can give rise to operational problems. As the user engages in activities which expose the pump to varying atmospheric pressures, such as for example, swimming or traveling in an air plane, differential pressures can arise between the interior of the air tight/water-resistant housing and the atmosphere. Should the pressure in the housing exceed external atmospheric pressure, the resulting forces could cause the reservoir piston to be driven inward thus delivering unwanted medication. Alternatively, should the pressure in the housing be less than the external pressure, the resulting forces could cause the infusion pump motor to work harder to advance the reservoir piston.

To address this problem, a preferred embodiment of the invention includes a vent which permits water resistant housing construction. The cap 12 includes a plurality of vent ports 24, only one of which is shown in FIG. 5. The vent ports 24 permit equalization of pump housing pressure to atmospheric pressure. Hydrophobic material (not shown) covers the interior openings of the vent ports 24. Hydrophobic material permits air to pass through the material while preventing water or other liquids from doing so, thus permitting water resistant venting. The preferred embodiment uses a hydrophobic material such as Gore-Tex®, PTFE, HDPE, or UHMW polymers from sources such as W. I. Gore & Associates, Flagstaff, Ariz., Porex Technologies, Fairburn, Ga., DeWAL Industries, Saunderstown, R.I, or Pall Specialty Materials, Port Washington, N.Y.

These materials are available in sheet form or molded (press and sintered) in a geometry of choice. Referring to FIGS. 14a-14 c, preferred methods to attach this material to the cap 12 include molding the hydrophobic material into a sphere 50 (FIG. 14a) or a cylinder 51 (FIG. 14b) and pressing it into a cavity in the pre-molded plastic housing. Alternatively, a label 52 (FIG. 14c) of this material could be made with either a transfer adhesive or heat bond material 53 so that the label could be applied over the vent port 24. Alternatively, the label could be sonically welded to the housing. In either method, air will be able to pass freely, but water will not.

In an alternative embodiment which is not shown, the venting is accomplished through a vent port located in the pump housing. This is described in greater detail in copending U.S. patent application Ser. No. 09/429,352, filed concurrently herewith, which application is incorporated by reference in its entirety. Alternatively, vent ports can be placed both in the cap 12 as well as the pump housing.

An advantage of placing the vent port and hydrophobic material in the cap 12, as opposed to in the pump housing only, is that the infusion set and its related connectors are disposable and are replaced frequently with each new reservoir or vial of medication. Thus, new hydrophobic material is frequently placed into service. This provides enhanced ventilation as compared with the placement of hydrophobic material in only the pump housing. Material in this location will not be replaced as often and thus is subject to dirt or oil build up which will retard ventilation.

As an alternative to the use of hydrophobic material, water can be prevented from flowing through the vent port by other apparatuses, such as the use of relief valves.

FIG. 6 shows a cross-sectional view of the reservoir/base/cap unit in accordance with the embodiment of FIGS. 3 and 4 which is secured into a pump housing 30. The threads 19 of the cap 12 engage the pump housing threads. Rather that the use of threads, an alternative embodiment (not shown) of the cap 12 could include detents extending radially from the exterior of the cap 12 which are adapted to engage detent openings in the pump housing.

The shoulder 23 portion of the cap 12 seats against the pump housing 30 to permit water tight construction. Further aiding in the water tight construction is an O-ring seal 31 which is disposed in the pump housing 30 and located just above the shoulder 23. In the preferred embodiment, the vent material 32 is comprised of hydrophobic material and is sonic welded to the upper interior surface of the cap 12. Alternatively, the vent material 32 could be attached to the cap 12 with an adhesive. The vent ports are not shown in FIG. 6.

Although the foregoing description of the venting was in connection with the embodiment of FIGS. 3-6, this feature is also applicable to the embodiment of FIGS. 1-2.

FIGS. 7 and 8 show an alternative embodiment of the cap 12. Referring to FIG. 7, a cap engagement member consists of a detent arm 34 which is formed in the upper portion of the cap 12. The purpose of the detent arm 34 is to securely engage the cap 12 into the pump housing. FIG. 8 shows a top view of the cap 12 positioned in the pump housing 30. The pump housing 30 has two case lock recesses 35 disposed in the circular rim of the housing. The detent arm 34 snaps into either of the case lock recesses 35. This engagement results in a “click” when the cap 12 is appropriately seated, thus providing both tactile and audible feedback to the user that the cap is securely engaged in the pump housing. Moreover, the detent arm 34 aligning with the recess 35 also serves as a visual indicator that the cap 12 is appropriately seated.

FIG. 9 shows an alternative embodiment of the cap 12 which contains a child safety feature. The cap 12 includes a locking member which consists of a safety tab 36 disposed in a groove 37. The safety tab 36 is sized such that it is able to slide along the length of the groove 37. When the safety tab 36 is in the position shown in FIG. 9, the detent arm 34 is unable to retract from its engaged position. Thus when the cap 12 is seated into the pump housing 30 (not shown) and the detent arm is seated into the case lock recess 35 (not shown), the safety tab 36 will prevent the detent arm 34 from disengaging from the case lock recess 35 thus more securely locking the cap 12 in the pump housing.

Thus for example, a parent could slide the safety tab 36 from the unlocked location in the groove 37 to the locked location shown in FIG. 9 so that it would be more difficult for a young child or infant to inadvertently remove the cap/base/reservoir unit from the pump housing. On the other hand, when the safety tab 36 is moved to the opposite end of the groove 37, the detent arm 34 is able to retract thus permitting removal of the cap 12 from the pump housing.

Although the foregoing description of the cap engagement member and child safety tab was in connection with the embodiment of FIGS. 3-9, this feature is also applicable to the embodiment of FIGS. 1-2.

FIG. 10 shows an exploded view of the cap 12 and the vent material 32. In the preferred embodiment, the vent material is made of hydrophobic material and is formed in a circular shape with a circular hole in the center. The vent material 32 is attached to the upper interior surface 38 of the cap 12 via sonic welding or an adhesive. When it is so attached, the needle 18 protrudes through the center hole of the vent material 32 but the interior openings of the vent ports 24 (not shown) are covered.

FIGS. 11 and 12 show an embodiment of the present invention where an adapter 40 is provided to allow a standard style syringe 41 with an integrated luer fitting 42 to be mounted and sealed in the pump housing. The syringe 41 is inserted through the center of the adapter 40 and held into place by a friction fit. The O-ring seal 43 in the adapter 40 seats against the syringe wall in order to prevent water and dirt from entering the pump housing.

A shoulder 45 is formed as part of the adapter 40 and is adapted to seat against the interior of the pump housing to form a water tight seal. Two tabs 44 are formed on the top surface of the adapter 40 and provide a surface for the user to grip the adapter 40 and twist it so that the adapter threads 19 engage the threads (not shown) of the pump housing. A detent arm 34 is formed in the upper portion of the adapter 40. Its purpose is to securely lock the adapter 40 into the pump housing (not shown) in the same manner as is shown in FIG. 8. Although not shown in FIGS. 11 and 12, the adapter 40 can further contain vent ports covered with hydrophobic material or a relief valve in order to permit water resistant venting of the pump housing in the same manner as previously described with other embodiments.

FIG. 13 shows another embodiment of the present invention where an interface is provided to connect a reservoir to a conduit, such as tubing, via a standard luer fitting connection. This allows a luer style disposable infusion set to connect to the pump housing (not shown). A cap 46 is formed with a luer fitting 47 portion as an integral part thereof. Except for the shape of the luer fitting 47 portion, the cap 46 has all of the other features of the cap 12 shown in FIG. 5. Thus referring to FIG. 13, the cap 46 is comprised of, among other things, threads 19, detent openings 14, a shoulder 23, vent ports 24, a detent arm 34, and a needle (not shown) disposed in the interior of the cap 46.

While the description above refers to particular embodiments of the present invention, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

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Classifications
U.S. Classification604/183
International ClassificationA61M5/168, A61J1/20, A61M39/10, A61J1/00, A61M5/162, A61J1/05, A61M5/145, F04B13/00, A61M39/00, F04B9/02, F04B23/00, A61M39/14, A61M5/20, A61M39/02, A61J1/14, A61M25/18, A61M39/12
Cooperative ClassificationA61M39/12, A61M5/16831, A61M2205/581, A61M39/14, A61M5/1456, A61M5/162, A61M39/10, A61M5/14566, A61M2205/582, A61M2005/1623, A61M5/1452
European ClassificationA61M5/145B10, A61M5/168D, A61M5/162, A61M39/12, A61M5/145B12
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